Manufacturing ExpertSingapore, Singapore
On the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:
- Small Molecules
- Cell and Gene
As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.
Takeda's Singapore biologics manufacturing facility focuses on manufacturing potentially life-saving medicines for patients suffering from rare blood disorders such as Hemophilia A and B. As part of the company’s Biologics Operating Unit network, the site is Takeda’s only biologics drug substance manufacturing facility in Asia. The facility has two buildings, including manufacturing suites and laboratories, as well as Takeda’s first positive energy building certified by Singapore’s Building and Construction Authority’s Green Mark scheme in 2022.
Job Title: Manufacturing Expert
Location: Woodlands, Singapore
About the role:
- With some supervision, the individual will support and coordinate routine GMP manufacturing life cycle and day to day operational activities associated with the products and process equipment in Takeda Singapore, including but not limited to Manufacturing Suite 1, Manufacturing Suite 2 and Manufacturing Support areas. In addition, the individual will provide critical ad hoc support to continuous improvement, validation and CAPEX activities.
How you will contribute:
The individual will support the EHS and cGMP compliance of day to day and tactical manufacturing activities and ensuring production activities are executed successfully. Primary responsibilities include: (70%)
- Work hand-in-hand with the shift teams to ensure adherence to the production plan, resolve issues, as required.
- Be considered to have more than one area of manufacturing expertise, for example, Upstream processing/Downstream processing/ Equipment Preparation/ Buffer Preparation and/or knowledge in key systems like EBM/XFP/CIP/SIP knowledge.
- Act as subject matter expert during audits, explaining and walking through specific process operations or investigations, as applicable.
- Carry out deviations investigations in the GEMS system, including product impact assessments and implement CAPAs.
- Be a change control owner in the CCMS system, if applicable
- Coordination of daily activities between shift teams and supporting functions
- Maintain recipe configuration management documentation, if applicable
- Carry out material support activities including liaising with MLCM or vendors to address material issues, if applicable
- Actively support the transfer of new processes and commissioning & validation activities of new projects, if applicable
- Informing management of events impacting production schedule
- Propose and review document revisions.
- Carry out work in a safe manner, notifying management of safety issues and risks
- Provide documentation support to Manufacturing, including document archival.
Provide administrative support to Manufacturing Standalone equipment, including system maintenance and data integrity management.
The individual will manage equipment and support facility related projects by: (20%)
- Able to lead investigations with the support of Operational Excellence or other functions.
- Contribute to continuous improvement.
- Able to lead investigations with the support of Operational Excellence or other functions.
- Contribute to continuous improvement
Staff Technical Training and Development: (10%)
- Meet and maintain training requirements on time.
- Provide technical training for shift personnel, as required.
- Develop training material, as required.
- Develop and maintain personal development plans.
- Participate in site or global strategic initiatives, as required.
- Provide feedback to peers to help staff development, as required.
- Provide annual performance self-assessment on development plan
- Responsibility to adhere to any applicable EHS requirements.
- Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.
- Any other duties as assigned by supervisor.
What you bring to Takeda:
Education and Experience Requirements
- Degree in Chemical Engineering / Bioengineering / Chemical & Biomolecular Engineering / Pharmaceutical Engineering or related and possesses 0 - 2 years of relevant experience in the biotechnology or pharmaceutical industry.
- Diploma in Applied Chemistry / Biomedical Sciences / Chemical Engineering / Food Science & Technology / Biologics & Process Technology / Chemical & Pharmaceutical Technology/ Food Science & Nutrition / Molecular Biotechnology / Biotechnology / Chemical & Biomolecular Engineering / Pharmacy Science or related and possess 2 - 4 years of relevant experience in the biotechnology or pharmaceutical industry.
- Nitec in Biotechnology / Chemical Process Technology or related with 4 - 6 years of relevant experience in the biotechnology, pharmaceutical industry.
- Excellent self-motivated team player with hands-on attitude and good communication skills
- Able to work on odd hours as required
Key Skills and Competencies
The individual should have good understanding of cGMP manufacturing aspects and had hands-on manufacturing experience.
- Proficient at technical writing as required for Electronic Batch Management (EBM), Batch Records (MBRs, MFRs) and Standard Operating Procedures (SOPs).
- Possess good communication and presentation skills.
- Possess good troubleshooting skills and critical thinking.
- Full awareness of current Good Manufacturing Practices (cGMP)
- Proficient documentation skills and computer skills including Microsoft Excel/Word/PowerPoint
- Good time management skills
- Ability to work in a matrix environment.
- Understanding of requirements from support functions and their capabilities
- Experience as a system user of business systems such as C3ME, XFP and Trackwise
- Will work holidays and overtime as required.
- May be required to adjust work schedule to meet production demands.
- Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.
- Ability to grow and gain entry to biotechnology/pharmaceutical manufacturing areas.
- May be required to stand for 6 hours in a production suite.
- May be required to climb ladders and work platforms.
- May be required to stoop or bend to check or trouble-shoot equipment.
- May be required to work around chemicals (alcohols, acids & bases)
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.
LocationsSGP - Singapore - Woodlands
Time TypeFull time
Working at Takeda
InclusionHere, you will feel welcomed, respected, and valued as a vital contributor to our global team.
CollaborationA strong, borderless team, we strive together towards our priorities and inspiring mission.
InnovationBold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top WorkplaceRecognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.
Work-LifeOur people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
EmpowermentThrough trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
Create an exceptional people experience.
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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